Trial Outcomes & Findings for A Safety Study of Sacubitril/Valsartan in Japanese Pediatric Patients With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction Who Have Completed CLCZ696B2319E1 Study (NCT NCT06149104)
NCT ID: NCT06149104
Last Updated: 2025-10-14
Results Overview
Number of participants with treatment emergent adverse events (any AE regardless of seriousness), and SAEs.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
8 participants
Primary outcome timeframe
Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.
Results posted on
2025-10-14
Participant Flow
Participants took part in 6 investigative sites in Japan.
All consenting participants were assessed for eligibility into this study at the first visit (Visit Day 1) and the study medication was initiated.
Participant milestones
| Measure |
Sacubitril/Valsartan
The starting dose of study drug was determined by the investigator in consideration of the participant´s condition. The dose level at the end of study visit of CLCZ696B2319E1 study could remain the same, or the dose level could be changed at the discretion of the investigator. All participants had a target dose of 3.1 mg/kg bid. If a participant was unable to tolerate up-titration to a higher sacubitril/valsartan dose level or at the discretion of the Investigator, participants could be maintained on lower dose levels of sacubitril/valsartan.
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|---|---|
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Overall Study
STARTED
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8
|
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Overall Study
COMPLETED
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8
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Safety Study of Sacubitril/Valsartan in Japanese Pediatric Patients With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction Who Have Completed CLCZ696B2319E1 Study
Baseline characteristics by cohort
| Measure |
Sacubitril/Valsartan
n=8 Participants
The starting dose of study drug was determined by the investigator in consideration of the participant´s condition. The dose level at the end of study visit of CLCZ696B2319E1 study could remain the same, or the dose level could be changed at the discretion of the investigator.
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|---|---|
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Age, Continuous
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6.75 years
STANDARD_DEVIATION 4.234 • n=5 Participants
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Sex: Female, Male
Female
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6 Participants
n=5 Participants
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Sex: Female, Male
Male
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2 Participants
n=5 Participants
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Race/Ethnicity, Customized
Asian
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8 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.Population: Safety Set (SAF): all participants who received at least one dose of open-label study treatment.
Number of participants with treatment emergent adverse events (any AE regardless of seriousness), and SAEs.
Outcome measures
| Measure |
Sacubitril/Valsartan
n=8 Participants
The starting dose of study drug was determined by the investigator in consideration of the participant´s condition. The dose level at the end of study visit of CLCZ696B2319E1 study could remain the same, or the dose level could be changed at the discretion of the investigator.
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|---|---|
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Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Adverse Events
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6 Participants
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Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Serious Adverse Events
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1 Participants
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Adverse Events
Sacubitril/Valsartan
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
All Patients
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sacubitril/Valsartan
n=8 participants at risk
The starting dose of study drug was determined by the investigator in consideration of the participant´s condition. The dose level at the end of study visit of CLCZ696B2319E1 study could remain the same, or the dose level could be changed at the discretion of the investigator.
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All Patients
n=8 participants at risk
All Patients
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|---|---|---|
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Infections and infestations
Upper respiratory tract infection
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12.5%
1/8 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.
|
12.5%
1/8 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.
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Respiratory, thoracic and mediastinal disorders
Asthma
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12.5%
1/8 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.
|
12.5%
1/8 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.
|
Other adverse events
| Measure |
Sacubitril/Valsartan
n=8 participants at risk
The starting dose of study drug was determined by the investigator in consideration of the participant´s condition. The dose level at the end of study visit of CLCZ696B2319E1 study could remain the same, or the dose level could be changed at the discretion of the investigator.
|
All Patients
n=8 participants at risk
All Patients
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|---|---|---|
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Gastrointestinal disorders
Vomiting
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12.5%
1/8 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.
|
12.5%
1/8 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.
|
|
Immune system disorders
Seasonal allergy
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12.5%
1/8 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.
|
12.5%
1/8 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.
|
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Infections and infestations
COVID-19
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12.5%
1/8 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.
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12.5%
1/8 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.
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|
Infections and infestations
Gastroenteritis
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12.5%
1/8 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.
|
12.5%
1/8 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.
|
|
Infections and infestations
Influenza
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12.5%
1/8 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.
|
12.5%
1/8 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.
|
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Infections and infestations
Nasopharyngitis
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25.0%
2/8 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.
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25.0%
2/8 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.
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Infections and infestations
Otitis media
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12.5%
1/8 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.
|
12.5%
1/8 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.
|
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Infections and infestations
Streptococcal infection
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12.5%
1/8 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.
|
12.5%
1/8 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.
|
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Infections and infestations
Upper respiratory tract infection
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12.5%
1/8 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.
|
12.5%
1/8 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.
|
|
Infections and infestations
Urinary tract infection
|
12.5%
1/8 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.
|
12.5%
1/8 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.
|
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Metabolism and nutrition disorders
Hypoglycaemia
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12.5%
1/8 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.
|
12.5%
1/8 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.
|
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Musculoskeletal and connective tissue disorders
Muscle tightness
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12.5%
1/8 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.
|
12.5%
1/8 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
12.5%
1/8 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.
|
12.5%
1/8 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.
|
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Skin and subcutaneous tissue disorders
Eczema
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12.5%
1/8 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.
|
12.5%
1/8 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER